Amgen is a values-based organization with a powerful sense of shared purpose toward our mission: to serve patients. We provide the capabilities, resources, and rewards of a global enterprise, while maintaining the entrepreneurialism and pioneering spirit that marked our early days as a biotechnology innovator. We encourage our team members to have fulfilling and meaningful careers through challenging assignments, career development, and valuable opportunities such as this job opportunity.
At Amgen Breda, The Netherlands, we focus on the packaging and distribution part of the drugs we have developed which are produced at our international sites. The packaging and distribution is supported by the Operations, Customer Service and Demand, Information Systems and Quality departments.
The site also supports a sales organization.
Process Development, Operations and Quality (POQ) are the core divisions of Amgen that make sure the drugs are delivered to our patients. Made up of seven functions and spread across seven sites, POQ’s aspiration is simple: Supply every patient, every time!
We are currently looking for an Associate Quality Assurance
In this role you ensure IDP/ FDP batches are ready for release by the Qualified Person (QP) and all procedural requirements for release have been met. You execute sampling, inspection, review and release of incoming materials. and you execute sampling and/or inspection of IDP / FDP / NAMP.
You perform GMP compliance checks in the warehouse area. You initiate and own class 1 deviationsrelated to IQA and Warehouse activities. And you establish effective working relationships with warehouse, QA management and the Qualified Person.
What will you do?
•Samplingand Inspection of IDP and review completed IDP batch records ensuring all procedural requirements aremet– QCLab data authorization inLIMS–Testsample planning and sample management (coordination between AML, ADL,ABR and Test Labs)
•Sampling and Inspection of FDP and review completed FDP batch records ensuring all procedural requirements are met
•Sampling, inspection, review and release of printed and non-printed packaging components & “Non-Amgen Medicinal Products”
•Review temperature data of shipments received at ABR
•Preparing samples for shipment to contract laboratories
•Perform GMP compliance checks in Warehouse
•Provide QA oversight for: regulatory labeling in the WH–Issues upon receipt of components / IDP / FDP / NAMP–Destruction Authorizations–Cancelled Ship Confirmed Orders
•Initiate and own class 1 deviations related to IQA and WH activities
•Own training material related to own processes.
•Trainer for IQA related processes.
What do you bring?
•Associate’s degree (MBO), bachelor’s degree (HBO), professional secretarial education or equivalent
•Pharmaceutischvakmancertificate
•Pass Amgen’s test for colorblindness
•Accurate mindset
•PharmaceutischTechnicuscertificate is preferred
•Typically 3 or more years related professional experience, preferably in the pharmaceutical industry is also preferred.
Amgen is a Fortune 150 company operating in nearly 100 countries around the world, we invest in highly skilled, dedicated and collaborative individuals who are ready to contribute to our mission in meaningful ways and make a difference in the lives of our patients.
That’s why, as a member of the Amgen team, we provide you with valuable opportunities to broaden your experience and maximize your potential. We ensure our staff are equipped to excel today and tomorrow by leveraging state-of-the-art technologies and modern working environments, encouraging open dialogue and professional debate, and collaborating with world-class talent and institutions around the globe. We believe in rewarding those who do rewarding work and are committed to providing careers that can help turn the tide of serious, life-interrupting illnesses.
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